Endotracheal intubation tube is a typical and effective device for providing air flow to the lungs of a patient, particularly an unconscious patient under general anesthesia. For air or oxygen to reach the human lungs, it has to travel through a patent conduit through the mouth, the vocal cords, the larynx, the trachea, and down to the lungs. The endotracheal intubation tube (hereinafter known as EIT) comprises a flexible tube which commonly has an inflatable cuff near its distal end. The EIT is inserted into the trachea, which is the tube like structure that connects the mouth and the larynx to the lungs, in a procedure called “intubation.” Intubation is usually performed by a trained medical professional, commonly an anesthesiologist, when the patient is unconscious due to general anesthesia or a certain medical emergency that causes loss of consciousness such as trauma, seizures, heart attacks or other. Intubation is done by inserting an “intubation blade” held by one hand into the mouth of the patient and inserting the EIT, held by the other hand, into the trachea under direct vision of the vocal cords, which constitute the door to the larynx. Intubation is usually done to ensure that the unconscious patient, while unable to breathe spontaneously, will still receive oxygen to his or her lungs, which is an indispensible process in order to maintain life. However, in many patients, conventional intubation as described above is very difficult or impossible and often is ineffective due to provider related factors (lack of expertise or specialized training), or more commonly patient's related factor (obesity, unusual anatomy, swelling of the soft tissues due to fluids or trauma or many other factors) which hinder the direct visualization of the tracheal opening or access of the EIT to the trachea. This usually results in bad consequences to the patients including death, permanent brain damage and/or heart attacks within few minutes after loss of oxygen flow to the lungs.
U.S. Patent Application Publication No. 2010/0313895 discloses an adjustable endotracheal tube adapted to increase in diameter after the tube is placed into the trachea. The adjustable endotracheal tube improves upon previously known endotracheal tubes in that it allows for adjustment of the diameter of the tube by means of a balloon. The balloon is used to seal against the tracheal passageway. The balloon conforms to the trachea walls to form the air seal. This device does not provide any advantage over the traditional EIT as a rescue device since it must be placed in the trachea in an identical way to the traditional EIT, and it actually could be more difficult to place due to its bigger size compared to the traditional EIT.
A laryngeal mask airway is used on the patient when the traditional endotracheal intubation is not effective. The laryngeal mask airway (hereinafter LMA) comprises an airway tube and an inflatable mask at the distal end of the airway tube. The mask can easily be inserted into the pharynx of the patient and then inflated to seal against the laryngeal inlet. LMAs come in a variety of sizes ranging from large adult sizes to infant sizes. The laryngeal mask functions as a peripharyngeal sealer. The LMA includes an open end pointing down towards the tongue which pushes back towards the uvula. The cuff follows the natural bend of the oropharynx, and is seated over the pyriform fossae. Once in position, the cuff around the mask is slightly inflated to create a tight air seal. The LMA is not inserted into the trachea as with the EIT but lies in the posterior compartment of the mouth, in proximity to the laryngeal inlet, which is the entry point of the human respiratory system.
U.S. Pat. No. 5,623,921 granted to Kinsinger et al. discloses a laryngeal mask airway similar to the LMA as described above. The airway tube includes a first tube section having a distal end connected to the mask and a second separable tube allowing it to split away from the first tube. The LMAs as disclosed in the '921 patent are well known and common representations of LMAs known in the field of anesthesia.
However, the EITs and LMAs as disclosed above are often still not effective to resuscitate the unconscious patient. LMA is NOT a perfect device. The main advantages of the LMA are that it is much easier to use, it could be placed in position in a relatively shorter time than an EIT in an emergency situation, and, it does not require a highly trained personnel to place it. The biggest disadvantage is that LMA does NOT provide a direct connection to the trachea with resulting high probability of failure to guarantee the flow of oxygen to the lungs. Death and other severe injuries still occur despite the appropriate use of the LMA. The main reason is that soft tissues in the mouth become relaxed, heavy and redundant after the patient loses consciousness, thus collapsing into the mouth and potentially preventing any air flow from the mouth, where the LMA is situated, to the trachea. If the EIT is ineffective, the medical personnel will frequently reach for the LMA to resuscitate the patient. If the LMA is ineffective to resuscitate the patient, the personnel is left with very limited options to save the patient's life, which are most likely surgical and require the immediate availability of a surgeon who is trained to make a surgical opening in the neck in order to bypass the mouth.
Accordingly, there exists a need in the art to provide an adjustable airway device with similar advantage to the LMA but which will operate to displace the soft tissues in the mouth of the unconscious patient so as to facilitate air flow into and/or out of the lungs of a patient thereby resuscitating the patient and saving the patient's life.